Page 96 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A010 SOP Title: RA Contracts
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe procedures to be followed for review and processing of study contracts.
2. INTRODUCTION
Children’s Health requires contracts be in place when conducting business with outside vendors.
3. SCOPE
This SOP applies to Research Administration (RA), Research Finance, Contracts Management and Legal.
4. RESPONSIBILITIES
4.1 Research Administration
RA is responsible for receiving and processing all contracts related to clinical research studies. These include, but is not limited to, Facility Use Agreements (FUA), Service Order Agreements (SOA), Labor Service Order Agreement (Labor SOA) Statement of Work (SOW) Data Use Agreements (DUA), and Reliance Agreements.
Senior Director and/or Director of Research Administration
The Director of RA shepherds the contract review process and ensures the contract is routed through the proper channels for approval and final signature. In the Director’s absence, the Senior Director of RA will assume these responsibilities.
Contracts Management
Contracts Management is responsible for routing the contract through the Lawson Contracts Management System (LCMS) for approval and signatures. routing contracts to the sponsor, when applicable, for final signature and notifying either the Director of RA or the Director of Finance (Labor SOA/SOW) when contracts are expiring (the first notification occurs at 180 prior to the expiration date).
Contracts are routed through the Lawson Contracts Management System (LCMS), for approval and/or signature, and to track expiration dates. However, different contracts have different processes, which are outlined below.
5. SPECIFIC PROCEDURE
5.1 Facility Use Agreements (FUA)
FUA’s are required for ALL industry sponsored trials and should be initiated as soon as it is confirmed that our institution has been selected to participate in an industry- sponsored study. The FUA must be initiated through RA and cannot be signed by the PI, any member of the research team, or any agent of UTSW.
The Research Administrative Coordinator (RAC) will send either the generic template, or a sponsor specific template to the sponsor contact. Once redlines are received, the RAC and Director will facilitate negotiations between the sponsor and the CHST legal team. Templates are located here: T:\CLINICAL RESEARCH\_Facility Use
Page 2 of 6